ISCR notes positive response of regulatory authorities, hopeful of return of business for trials

Nandita Vijay, Bengaluru
Tuesday, August 5, 2014, 08:00 Hrs [IST]

Indian Society for Clinical Research (ISCR) views that the response of the regulatory authorities on the concerns raised by clinical research organisations (CROs) about some of the challenging guidelines makes it hopeful that issues will be ironed out and India could be back-in-business for human studies.

“However, winning back the confidence of the CROs will be a challenging and uphill task. Given some of the sensationalism and misinformed reporting of clinical research in India, there is a need to garner the trust of investigators in conducting clinical research in the country and of the general public in participating in clinical research. It will take several months before we see clinical research back in India on track,” Suneela Thatte, president ISCR told Pharmabiz.

The current regulatory environment has created a crisis in the confidence of CROs and patients. Several Indian companies, have publicly stated their decision to move their clinical research overseas.”We need to restore confidence amongst all stakeholders in doing clinical research in India so that we do not lose out in the quest to discover and develop new medicines and in ensuring that our patients have access to these medicines”, she added.

There is need for more collaborative approach in the development of policies and guidelines that have a stakeholder feedback mechanism along with additional capacity and infrastructure at the regulatory end. There is need for consistency and stability in the regulatory office, openness, transparency and quicker responsiveness on issues addressed. All of this must however be guided by a policy framework that places clinical research at the forefront of a health agenda for the country.

One of the focus areas of the new government is on public health education and awareness. India needs to foster an environment where patients participating in clinical research and investigators undertaking human studies do not do so in fear of its consequences. Public health education on the value of clinical research and the rights and responsibilities of patients is much needed to address the misinformation and negative perceptions that exist about the clinical research process.

However, some initiatives like the compensation guidelines, mandatory audio- visual recording of informed consent for all clinical trial patients which disregards socio-cultural and religious sensitivities in our country and restricting the number of studies that an investigator can undertake to an arbitrary number have been knee jerk reactions to environmental pressures, do not provide adequate guidance and go against the basic principles of research as also patient interest, said the ISCR president.